The percentage of the world population suffering from morbid obesity is steadily increasing. Some estimates show the number of people that suffer from morbid obesity in the United States alone exceeds 10 million, and the deaths of an estimated 500,000 people could be related to obesity. Severely obese people are susceptible to an increased risk of many medical conditions, including heart disease, stroke, diabetes, pulmonary disease, hypertension, gall bladder disease, osteoarthritis, sleep apnea and other breathing problems, some forms of cancer (e.g., uterine, breast, colorectal, kidney, and gall bladder), accidents, and death.
Surgical treatment options for treating obesity are growing and being performed at an increasing rate. These approaches can generally be categorized as either malabsorptive or restrictive. Absorptive procedures modify the gastrointestinal tract so that only a small fraction of the food and fluid intake is actually digested; restrictive procedures limit an amount of food and fluid intake. Following a restrictive procedure, a patient's ability to eat is severely restricted. The patient can only eat a limited amount of food and fluid and any attempt to eat more will result in varying degrees of discomfort.
A leading surgical approach for treating obesity is often referred to as the Roux-en-Y gastric bypass procedure. A Roux-en-Y procedure combines restrictive and malabsorptive approaches by restricting the stomach and bypassing a proximal portion of the small intestine. The stomach is typically restricted by stapling at least a portion of the stomach to create a pouch, effectively limiting the size of a patient's stomach and thereby limiting a patient's food and fluid intake. Staple line failures, however, are a known problem of Roux-en-Y gastric bypass procedures. When a staple line fails, the patient can regain weight. It also can cause the body to be exposed to undesirable outside materials, such as stray staples. To prevent staple line failure, some surgeons practice additional techniques to make the division more secure, for example by suturing off the pouch from the portion of the stomach that is to remain a part of the digestive tract. The creation of pouches, however, is not generally desirable because they can result in stenosis, e.g., stricture of the stomach stoma that can have a major effect on a patient's eating, and dilation, e.g., stretching of the stomach that can result in weight gain. It is currently believed that about 5 to 10 percent of Roux-en-Y patients have dilation problems and about 2 percent have intestinal obstruction. Further, metabolic complications can also occur following a Roux-en-Y procedure, such as anemia and calcium deficiency, because essential vitamins and nutrients of blood production (e.g., iron and vitamin B12) depend on the stomach and intestine for absorption, and because calcium is best absorbed in the duodenum, which is bypassed in a Roux-en-Y procedure. Still further, current procedures like Roux-en-Y are difficult to adjust and impossible to reverse, despite the fact that it can be desirable to make adjustments to the gastric bypass for the patient or even reverse the gastric bypass entirely.
It is thus desirable to provide a new surgical procedure for treating obesity that does not create pouches in the stomach, does not use staples, and which can be easily adjusted or even reversed.
Further, mitral regurgitation is the most prevalent form of valvular heart disease. Surgical therapy for mitral valve regurgitation is common with approximately 20,000 procedures performed in the United States each year. Operative strategies and techniques have progressed significantly since the early experience with emphasis on mitral valve repair instead of replacement. Subsequently, the mortality rate for surgical mitral valve repair is now less than 5% and lasting results (freedom from re-operation), particularly when treating primary mitral regurgitation are reported to be greater than 90% at five years at follow-up. Recently, a new paradigm has emerged for the treatment of mitral regurgitation. This is based on percutaneous techniques and the experiences of both cardiac surgeons and interventional cardiologists.
It is thus also desirable to provide new surgical procedures for repairing a heart valve.